Worksheet No. NRP-002A.doc Page 1 of 10

Transcription

1 Worksheet No. NRP-002A.doc Page 1 of 10 WORKSHEET for Evidence-Based Review of Science for Emergency Cardiac Care Worksheet author(s) Colm P.F O Donnell Date Submitted for review: 3 rd February 2010 Clinical question. In neonates (preterm and term) receiving respiratory support (P), does the use of CPAP (I) versus no CPAP or IPPV (C) improve patient outcome specify (O)? Is this question addressing an intervention/therapy, prognosis or diagnosis? Intervention State if this is a proposed new topic or revision of existing worksheet: New topic Conflict of interest specific to this question Do any of the authors listed above have conflict of interest disclosures relevant to this worksheet? No Search strategy (including electronic databases searched). PubMed Search 1. Infant, newborn AND respiration, artificial AND resuscitation AND CPAP Search 2. Infant, newborn AND respiration, artificial AND resuscitation AND continuous positive airways pressure The Cochrane Central Register of Controlled Trials (CENTRAL) Search 1. Infant, newborn AND respiration, artificial AND resuscitation AND CPAP Search 2. Infant, newborn AND respiration, artificial AND resuscitation AND continuous positive airways pressure EMBASE Search 1. 'newborn'/exp OR newborn AND ('resuscitation'/exp OR resuscitation) AND positive AND 'end expiratory' AND ('pressure'/exp OR pressure) State inclusion and exclusion criteria Inclusion studies of CPAP versus no treatment, supplemental oxygen or intermittent positive pressure ventilation (PPV) in newly born human infants. Exclusion animal studies Number of articles/sources meeting criteria for further review: Pub Med Search1 of 111 citations retrieved Morley CJ, Davis PG, Doyle LW, Brion LP, Hascoet JM, Carlin JB, COIN trial investigators. Nasal CPAP or intubation at birth for very preterm infants. N Engl J Med. 2008; 358: Finer NN, Carlo WA, Duara S, Fanaroff AA, Donovan EF, Wright LL, Kandefer S, Poole WK, National institute of Child health and Human Development Neonatal Research Network. Delivery room continuous positive airway pressure/positive end-expiratory pressure in extremely low birth weight infants: a feasibility trial. Pediatrics 2004; 114: Sandri F, Ancora G, Lanzoni A et al. Prophylactic nasal continuous positive airways pressure in newborns of weeks gestation: multicentre randomised controlled clinical trial. Arch Dis Child Fetal Neonatal Ed 2004; 89: F394-F398 Zaharie G, Ion DA, Schmidt N, Popa M, Kudor-Szabadi L, Zaharie T. Prophylactic CPAP versus therapeutic CPAP in preterm newborns of gestational weeks. Pneumologia (Bucharest, Romania) :1 (34-37) Miksch RM, Armbrust S, Pahnke J, Fusch C. Outcome of very low birth weight infants after introducing a new standard regime with the early use of nasal CPAP. Eur J Pediatr 2008; 167: Aly H, Massaro AN, Patel K, El-Mohandes AA. Is it safer to intubate premature infants in the delivery room? Pediatrics 2005; 115: Hansen BM, Hoff B, Greisen G, Mortensen EL; Danish ETFOL Study Group. Early nasal continuous positive airway pressure in a cohort of the smallest infants in Denmark: neurodevelopmental outcome at five years of age. Acta Paediatr. 2004; 93: Lindner W, Vossbeck S, Hummler H, Pohlandt F. Delivery room management of extremely low birth weight infants: spontaneous breathing or intubation? Pediatrics 1999; 103: Gittermann MK, Fusch C, Gittermann AR, Regazzoni BM, Moessinger AC. Early nasal continuous positive airways pressure treatment reduces the need for intubation in very low birth weight infants. Eur J Pediatr 1997; 156: Millet V, Lacroze V, Bartoli JM, Samperiz S, Leclaire M, Unal D. Early continuous positive airways pressure in the labour room (French). Arch Pediatr 1997; 4: 15-20

2 Worksheet No. NRP-002A.doc Page 2 of 10 Search 2 3 of 177 citations retrieved Morley CJ, Davis PG, Doyle LW, Brion LP, Hascoet JM, Carlin JB, COIN trial investigators. Nasal CPAP or intubation at birth for very preterm infants N Engl J Med. 2008; 358: te Pas AB, Walther F. A randomized, controlled trial of delivery-room respiratory management in very preterm infants. Pediatrics 2007; 120; Finer NN, Carlo WA, Duara S, Fanaroff AA, Donovan EF, Wright LL, Kandefer S, Poole WK, National institute of Child health and Human Development Neonatal Research Network. Delivery room continuous positive airway pressure/positive end-expiratory pressure in extremely low birth weight infants: a feasibility trial. Pediatrics 2004; 114: CENTRAL Search 1 0 citations retrieved Search 2 1 citation retrieved Finer NN, Carlo WA, Duara S, Fanaroff AA, Donovan EF, Wright LL, Kandefer S, Poole WK, National institute of Child health and Human Development Neonatal Research Network. Delivery room continuous positive airway pressure/positive end-expiratory pressure in extremely low birth weight infants: a feasibility trial. Pediatrics 2004; 114: EMBASE 4 of 262 citations retrieved te Pas AB, Walther F. A randomized, controlled trial of delivery-room respiratory management in very preterm infants. Pediatrics 2007; 120; Halamek L.P., Morley C. Continuous positive airway pressure during neonatal resuscitation. Clin Perinatol :1 (83-98) Finer NN, Carlo WA, Duara S, Fanaroff AA, Donovan EF, Wright LL, Kandefer S, Poole WK, National institute of Child health and Human Development Neonatal Research Network. Delivery room continuous positive airway pressure/positive end-expiratory pressure in extremely low birth weight infants: a feasibility trial. Pediatrics 2004; 114: Unal D, Millet V. Neonatal resuscitation and preventive continuous positive airways pressure (French). Pédiatrie 1992; 47:

3 Worksheet No. NRP-002A.doc Page 3 of 10 Summary of evidence Evidence Supporting Clinical Question Good Vanpee 2007 C Gittermann 1997 C Lindner 1999 C Gregory 1971 C Unal 1992 C Millet 1997 C Aly 2005 C Miksch 2008 C Avery 1987 C Van Marter 2000 C Fair te Pas 2007 C Poor Zaharie 2008 C Level of evidence A = Return of spontaneous circulation C = Survival to hospital discharge E = Other endpoint B = Survival of event D = Intact neurological survival Italics = Animal studies

4 Worksheet No. NRP-002A.doc Page 4 of 10 Evidence Neutral to Clinical question Good Fair Morley 2008 C Sandri 2004 C Subramaniam 2005 C Finer 2004 C Rojas 2009 C Poor Level of evidence A = Return of spontaneous circulation C = Survival to hospital discharge E = Other endpoint B = Survival of event D = Intact neurological survival Italics = Animal studies Evidence Opposing Clinical Question Good Fair Poor Level of evidence A = Return of spontaneous circulation C = Survival to hospital discharge E = Other endpoint B = Survival of event D = Intact neurological survival Italics = Animal studies

5 Worksheet No. NRP-002A.doc Page 5 of 10 REVIEWER S FINAL COMMENTS AND ASSESSMENT OF BENEFIT / RISK: CPAP has been used to support preterm infants with respiratory distress for more than 30 years (Gregory 197) and has been employed as the primary mode of respiratory support for such infants in certain centres for many years. The use of CPAP started in the delivery room or shortly after birth in preterm infants has been associated with a reduction in the rate of intubation and mechanical ventilation in single centre retrospective cohort studies (Unal 1992, Gittermann 1997, Millet 1997, Lindner 1999, Aly 2005, Zaharie 2008, Miksch 2008). Also, the use of CPAP in preference to endotracheal mechanical ventilation has been associated with reduced rates of chronic respiratory insufficiency among preterm infants in studies of contemporaneous cohorts treated in different hospitals in the pre- (Avery 1987) and post-surfactant eras (Van Marter 2000, Vanpee 2007); and in retrospective cohort studies in the same hospitals (Lindner 1999, Miksch 2008). In most studies, infants have started CPAP on admission to the intensive care nursery rather than in the delivery room. No reduction in the rate of mechanical ventilation or surfactant treatment was demonstrated in a randomised trial which started CPAP at about 30 minutes in larger preterm (28-31 weeks) infants (Sandri 2004). A meta-analysis of this and a further randomised trial concluded that neither trial demonstrated a reduction in the rate of subsequent mechanical ventilation among infants who were treated with prophylactic CPAP and that there was insufficient information to evaluate the effectiveness of prophylactic nasal CPAP (Subramaniam 2005). A recent trial which enrolled relatively mature preterm infants (27-31 weeks gestation) with respiratory distress who started CPAP at minutes of age and compared brief intubation for surfactant administration within the first hour of life to continuation on CPAP showed a reduction in the need for subsequent intubation,/mechanical ventilation, surfactant treatment and pneumothorax in the group who received surfactant (Rojas 2009). There was no difference in the rate of chronic lung disease between the groups. A trial comparing the effect of giving surfactant early or relatively later in the course of RDS in infants treated with CPAP has been reported and publication is awaited (Plavka 2008). Among trials where infants were started on CPAP in the delivery room: One pilot trial confirmed the feasibility of randomising infants weeks gestation to treatment with CPAP or supplemental oxygen; it was not powered to examine outcomes of clinical importance and did not show differences between the groups (Finer 2004) In a further trial infants < 32 weeks gestation with respiratory distress were randomised to receive either PPV with a self-inflating bag and mask or a multi-faceted respiratory intervention which included starting CPAP in the delivery room. Infants randomised to the multi-faceted intervention had lower rates mechanical ventilation within 72 hours (385 v 52%) and of bronchopulmonary dysplasia (see Table below). Due to the multi-faceted nature of the intervention it is not possible to determine the relative contribution of any part of the intervention including CPAP to the differences observed between the groups (te Pas 2007). One large randomised trial which compared CPAP to endotracheal ventilation for respiratory support of spontaneously breathing infants with respiratory distress born at weeks gestation (Morley 2008). The outcomes of both groups were similar. A difference in the proportion of infants dead or receiving oxygen at 28

6 Worksheet No. NRP-002A.doc Page 6 of 10 days favouring infants started on CPAP (see Table 3 below) was not seen at 36 weeks post menstrual age (see Table 2 below). The rates of mechanical ventilation (46% vs. 100%) and surfactant use (38% vs. 77%) was halved in those started on CPAP; and the rate of pneumothorax was higher among infants started on CPAP (9% vs. 3%) see Table 4 below.

7 Worksheet No. NRP-002A.doc Page 7 of 10

8 Worksheet No. NRP-002A.doc Page 8 of Trials comparing early CPAP with intubation to prophylactic surfactant administration and mechanical ventilation ( and both of these strategies to a brief period of intubation for surfactant administration and early extubation to CPAP ( are completed awaiting report and ongoing respectively. Acknowledgements: Citation List Aly H, Massaro AN, Patel K, El-Mohandes AA. Is it safer to intubate premature infants in the delivery room? Pediatrics Jun;115(6): Level of evidence 4 Avery ME, Tooley WH, Keller JB, Hurd SS, Bryan MH, Cotton RB, Epstein MF, Fitzhardinge PM, Hansen CB, Hansen TN et al. is chronic lung disease in low birth weight infants preventable? A survey of eight centers. Pediatrics 1987; 79: Comment: Carefully performed study comparing large centres in the pre-surfactant era showing striking differences in chronic lung disease. Level of evidence: 5 Finer NN, Carlo WA, Duara S, Fanaroff AA, Donovan EF, Wright LL, Kandefer S, Poole WK, National institute of Child health and Human Development Neonatal Research Network. Delivery room continuous positive airway pressure/positive end-expiratory pressure in extremely low birth weight infants: a feasibility trial. Pediatrics 2004; 114: Level of evidence 1 Quality Fair Gittermann MK, Fusch C, Gittermann AR, Regazzoni BM, Moessinger AC. Early nasal continuous positive airway pressure treatment reduces the need for intubation in very low birth weight infants.. Eur J Pediatr 1997; 156: Comment: Reduction in intubation rate demonstrated Level of evidence 3 Gregory GA, Kitterman JA, Phibbs RH, Tooley WA, Hamilton WK. Treatment of the idiopathic respiratory distress syndrome with continuous positive airways pressure. N Engl J Med 1971; 284: Comment: Effect of CPAP given to severely ill infants with RDS so dramatic, it published as a case series of 20 infants in N Engl J Med. Level of evidence: 4 Lindner W, Vossbeck S, Hummler H, Pohlandt F. Delivery room management of extremely low birth weight infants: spontaneous breathing or intubation? Pediatrics. 1999; 103:

9 Worksheet No. NRP-002A.doc Page 9 of 10 Comment: Detailed study showing reduction in mechanical ventilation and chronic lung disease after the introduction of a delivery room strategy that included early CPAP. Level of evidence 3 Miksch RM, Armbrust S, Pahnke J, Fusch C. Outcome of very low birthweight infants after introducing a new standard regime with the early use of nasal CPAP. Eur J Pediatr Aug;167(8): Level of evidence 3 Millet V, Lacroze V, Bartoli JM, Samperiz S, Leclaire M, Unal D. Early continuous positive pressure in the labor room (French) Arch Pediatr 1997; 4: Comment: Good outcomes reported in a large series of infants treated with CPAP from birth. Level of evidence: 4 Morley CJ, Davis PG, Doyle LW, Brion LP, Hascoet JM, Carlin JB, COIN trial investigators. Nasal CPAP or intubation at birth for very preterm infants N Engl J Med. 2008; 358: Comment: Well designed and conducted trial which demonstrated no difference in the rate of death or oxygen therapy at 36 weeks between infants randomly assigned to CPAP or intubation in the delivery room. Benefits seen in the CPAP arm at 28 days were not seen at 36 weeks. Reduction in rates of mechanical ventilation and surfactant treatment were counter-balanced by an increase in the rate of pneumothoraces in the CPAP group. Level of evidence 1 Plavka R, Simeoni U, Sandri F and CURPAP Study Group. CURPAP study an international randomised controlled trial to evaluate the efficacy of combining prophylactic surfactant and early nasal continuous positive airway pressure in very preterm infants: preliminary results. Arch Dis Child 2008; 93: espr 23 Comment: Results presented, not yet published Level of evidence: Not applicable Quality: Not determinable Rojas MA, Lozano JM, Rojas MX, Laughon M, Bose CL, Rondon MA, Charry L, Bastidas JA, Perez LA, Rojas C, Ovalle O, Celis LA, Garcia-Harker J, Jaramillo ML, Colombian Neonatal Research Network. Very early surfactant without mandatory ventilation in premature infants with early continuous positive airways pressure: a randomized, controlled trial. Pediatrics 2009; 123: Level of evidence 4 Sandri F, Ancora G, Lanzoni A, Tagliabue P, Colnaghi M, Ventura ML, Rinaldi M, Mondello I, Gancia P, Salvioli GP, Orzalesi M, Mosca F on behalf of the Pneumology Study Group of the Italian Society of Neonatology. Prophylactic nasal continuous positive airways pressure in newborns of weeks gestation: multicentre randomised controlled clinical trial. Arch Dis Child Fetal Neonatal Ed 2004; 89: F394 F398 Comment: No benefit of starting CPAP found in terms of reducing mechanical ventilation, surfactant use or chronic lung disease. CPAP started relatively later (not in delivery room) among relatively mature infants (28-31 weeks) at low risk of chronic lung disease. Level of evidence 1

10 Worksheet No. NRP-002A.doc Page 10 of 10 Quality: Fair Subramaniam P, Henderson-Smart DJ, Davis PG. Prophylactic nasal continuous positive airways pressure for preventing morbidity and mortality in very preterm infants. Cochrane Database of Systematic Reviews 2005, Issue 3. Art. No.: CD DOI: / CD pub2. Level of evidence 1 Quality: Fair te Pas AB, Walther F. A randomized, controlled trial of delivery-room respiratory management in very preterm infants. Pediatrics 2007; 120; Comment: Well conducted trial but difficult to determine the relative contribution of early CPAP to the differences between the groups due to the multi-faceted nature of the intervention. Level of evidence 1 Quality: Fair Unal D, Millet V, Leclaire M. Neonatal resuscitation and preventive continuous positive pressure ventilation (French). Pediatrie 1992; 47: Comment: Feasibility of starting premature infants on CPAP in the delivery room without obvious detrimental effects demonstrated Level of evidence 4 Van Marter LJ, Allred EN, Pagano M, Sanocka U, Parad R, Moore M, Susser M, Paneth N,Leviton A. Do clinical markers of barotraumas and oxygen toxicity explain interhospital variation in rates of chronic lung disease? The Neonatology Committee for the Developmental Network. Pediatrics 2000; 105: Comment: Similar study to Avery 1987 showing similar striking differences in chronic lung disease in the postsurfactant era Level of evidence 5 Vanpée M, Walfridsson-Schultz U, Katz-Salamon M, Zupancic JA, Pursley D, Jónsson B. Resuscitation and ventilation strategies for extremely preterm infants: a comparison study between two neonatal centers in Boston and Stockholm. Acta Paediatr. 2007;96:10-6 Comment: Association between CPAP and better pulmonary outcome again demonstrated Level of evidence 2 Zaharie G, Ion DA, Schmidt N, Popa M, Kudor-Szabadi L, Zaharie T. T Prophylactic CPAP versus therapeutic CPAP in preterm newborns of gestational weeks. Pneumologia (Bucharest, Romania) 2008; 57:1: Comment: I was unable to get an English language translation of this paper, so I can t determine its quality. Level of evidence: 4 Quality: Cannot determine (allocated Poor in the grid)